510(k) · Cleared
ClearedSurgplan and Panplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Sciences Intl., Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 23, 2004 after a 241-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 23, 2004
- Review
- 241 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041078 Surgplan and PanplanImaging Sciences Intl., Inc. · 2004
- Descendant · cites it directly · 0 of its ownK051715 Starpacs DentalInfinitt Co., Ltd. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051715Starpacs DentalInfinitt Co., Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041078 | Surgplan and Panplan | Imaging Sciences Intl., Inc. | 2004 | — |
| +1 | K051715 | Starpacs Dental | Infinitt Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | SimPlant Named without a submission number | |
| * | — | CDRPan and CDR DICOM Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051715 | Starpacs Dental | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051715 (Infinitt Co., Ltd., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
SurgPLAN and PanPlan are Software packages that scan (scan film using optical scanner or Direct Digital Capture using Solid State Sensor) and store images produced by Imaging Sciences International's (or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to…
Read the full statement (111 words)
SurgPLAN and PanPlan are Software packages that scan (scan film using optical scanner or Direct Digital Capture using Solid State Sensor) and store images produced by Imaging Sciences International's (or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities and communication between multiple practitioners and to demonstrate treatment plan for the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041078: Surgplan and Panplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041078
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026